Sterile packaging system and method

Abstract

A sterile packaging system for an object requiring sterilization in a sterilization apparatus includes a base having a support surface and a plurality of sides configured to support the object requiring sterilization; a wrap sized to cover the sides of the base and the object requiring sterilization, the wrap having a body portion and a lower portion; a sealing interface between the lower portion of the wrap and the base, the sealing interface configured to form a continuous seal between the lower portion of the wrap and a first sealing surface; and a first drape movable between an unfolded position and a folded position, the first drape sized to cover at least a first portion of the support surface of the base in the folded position.

Description

[Technical Field]

[0001] The present invention relates to a sterile packaging system and a method for sterilizing surgical instruments and the like, and more particularly to a sterile packaging system having a base and a wrap and a method for using the same. [Background technology]

[0002] Cleaning and sterilization of surgical instruments, laboratory equipment, and medical devices is important in many fields, including, but not limited to, scientific research, veterinary medicine, and human medicine. For example, surgical instruments must be provided in a sterile state for use in surgical procedures. Several steps are typically taken to reduce the risk of introducing harmful microorganisms into patients or scientific research. First, the objects are decontaminated and pre-cleaned. Next, the objects are washed, rinsed, and dried. After the objects are thoroughly cleaned, they are sterilized. Sterilization refers to any process that eliminates, removes, inactivates, or kills bacteria and other types of live microorganisms. Live microorganisms include infectious agents (fungi, bacteria, viruses, or spores) present on surfaces or contained in compounds such as fluids, drugs, or biological media. Sterilization is accomplished by applying heat, steam, chemicals such as ethylene oxide (EO), irradiation, high pressure, filtration, or a combination thereof. Generally, surgical instruments, laboratory equipment, and medical devices must be sterilized to a high level of sterility assurance before use on the body. These devices include, for example, scalpels, hypodermic needles, endoscopes, and implantable medical devices (IMDs) such as artificial pacemakers.

[0003] A widely used method of heat sterilization is the high-pressure steam sterilizer (autoclave, sometimes called a converter). Autoclaves typically use steam heated to 121°C to 134°C. To achieve a certain degree of sterility, a holding time of at least 15 minutes at 121°C and 100 kPa or at least 3 minutes at 134°C and 100 kPa is required. Instruments packaged in layers of liquid and fabric require longer holding times because they take longer to reach the required temperatures.

[0004] One method of sterilization involves passing steam through a rigid container system, such as a cabinet. For effective sterilization, the steam must penetrate the contents of the cabinet evenly. Therefore, the cabinet must not be overcrowded, and bottle caps and containers must be left ajar. When the chamber is first heated, any remaining air must be removed. Indicators should be installed in hard-to-reach areas to ensure that the steam is actually penetrating there.

[0005] The vents are typically filtered before, during, and after sterilization to prevent particles or foreign objects from entering the cabinet. Once sterilization is complete, the filters must be removed and inspected by a medical professional to ensure the integrity of the sterilization process has not been compromised. If any damage to the filter is discovered during inspection, the sterilization process must be repeated with a new filter.

[0006] Another sterilization method involves wrapping trays of instruments, supplies, medical devices, or other such objects in packaging that sterilizes the tray contents and maintains their sterility until the packaging is opened. Traditionally, instruments requiring reprocessing are provided in vented trays, allowing the sterilant to flow through the tray and sterilize all surfaces. To maintain sterility after removal from the sterilizer, the trays are wrapped in a material that allows the sterilant to pass through while protecting the tray from microorganisms until use. A variety of packaging materials can be used for sterilization. These include woven fabrics made from cotton, cotton-polyester blends, or synthetic fiber blends, as well as nonwoven materials made from plastic polymers, cellulose fibers, or washed paper pulp compressed into sheets. When wrapping trays of instruments, supplies, medical devices, or other such objects in packaging materials, including but not limited to plastic wrap, tears or holes can occur in the packaging. When this occurs, the sterilization process must be repeated using new packaging. Packaging devices in this manner also increases the surface area that must be inspected after the sterilizer completes a sterilization cycle. Single instruments can be individually sterilized in peel pouches. Peel pouches protect the instruments from environmental contaminants and maintain their sterility after the sterilization process is complete. However, peel pouches are inefficient because they do not allow multiple instruments to be sterilized within the same peel pouch. Peel pouches must also be placed on their side in the sterilizer to allow for air evacuation, sterilant penetration, and to prevent moisture buildup. Peel pouches cannot accommodate multi-component implants. These components must be placed in separate peel pouches prior to sterilization, typically by gamma irradiation.

[0007] Alternatively, the trays are placed in a rigid container and then filtered, acting like plastic wrap to allow the sterilant through but prevent microorganisms from entering. This filter also allows the sterilant or its by-products to leak out. After the sterilization process is complete, the filter must be removed and inspected by a medical professional to ensure the integrity of the sterilization process is intact. If any damage to the filter is discovered during inspection, the sterilization process must be repeated with a new filter. Larger containers have been created to handle multiple trays, consolidate processes, and simplify the sterilization process. However, these containers are expensive to manufacture and require storage space. Additionally, large containers can hold multiple instruments, resulting in significant combined weight loads and requiring specialized lifting equipment to transport the containers in and out of the sterilizer and into storage.

[0008] After sterilization is complete, the tray containing the sterilized items may be removed from the rigid container and placed on the operating room back table. Prior to this placement, the operating room back table is draped with a disposable sterile drape that covers the table surface and maintains the sterile field. The drape is typically made of a strong, tear-resistant, absorbent material. Summary of the Invention

[0009] A first exemplary embodiment of the present disclosure provides a sterile packaging system for objects requiring sterilization in a sterilization apparatus. The sterile packaging system includes a base. The base has a support surface and first, second, third, and fourth sides. The support surface is configured to support the object requiring sterilization. The base has a length and a width. The system includes a wrap. The wrap is sized to cover the sides of the base and the object requiring sterilization. The wrap has a body portion and a bottom portion. The system includes a sealing device. The sealing device seals the bottom portion of the wrap to each of the first, second, third, and fourth sides of the base. The system includes first and second drapes. The length of the first drape is greater than the length of the base. The first drape is configured to substantially enclose at least a first portion of the support surface of the base. The second drape has a width greater than the width of the base and is configured to substantially enclose at least a second portion of the support surface of the base.

[0010] A second exemplary embodiment of the present disclosure provides a method for sterilizing items in a sterilization apparatus, the method comprising the steps of: Placing a sterilization wrap material having a body portion and a bottom portion over a base having sides and a support surface for the items to be sterilized, the sterilization wrap material sized to cover the base. Positioning a sealing device around a side of the base, the sealing device having a band including an inner portion, an outer portion and a compressible layer, the compressible layer surrounding the inner portion of the band. Compressing the compressible layer against the bottom of the wrap and the sides of the base to form a sealed volume surrounding at least one item to be sterilized.

[0011] A third exemplary embodiment of the present disclosure provides a sterile packaging system for objects that need to be sterilized in a sterilization apparatus. The sterile packaging system includes a base having a support surface and a depending skirt including sides. The support surface is configured to support the object. The system includes a wrap having a main body portion and a lower portion. The main body portion includes a top panel and upper edge panels. The upper edge panel includes a rigid material configured to substantially retain a selected shape. The top panel includes a transparent material that provides at least one transparent wall for viewing the object. A lower portion of the wrap includes lower edge panels configured to overlap the sides of the depending skirt. The system further includes a sealing device for sealing the lower portion of the wrap to the depending skirt of the base.

[0012] A fourth exemplary embodiment of the present disclosure provides a sterile packaging system for an object requiring sterilization in a sterilization apparatus. The sterile packaging system includes a base having a support surface and a continuous sealing surface. The support surface is configured to support the object requiring sterilization. The system further includes a first drape sized to cover at least a first portion of the object requiring sterilization, and a wrap sized to engage the continuous sealing surface and enclose the first drape and the object requiring sterilization.

[0013] A fifth exemplary embodiment of the present disclosure provides a method for preparing an object requiring sterilization in a sterilization apparatus, the method including placing the object requiring sterilization on a base, at least partially encasing the object requiring sterilization in a first drape, enclosing the object requiring sterilization at least partially encased in the first drape in a wrap, and engaging the wrap with a continuous sealing surface of the base.

[0014] A sixth exemplary embodiment of the present disclosure provides a method for sterilizing items in a sterilization apparatus, the method comprising the steps of: Placing a sterilization wrap material on a base having a support surface for the items to be sterilized, the sterilization wrap material having a first sealing surface and a first expandable portion having a plurality of folds, the first expandable portion being coupled to at least one of the first and second non-expandable portions. Sealing the first sealing surface of the sterilization wrap material in the deployed configuration to form a sealed volume surrounding at least one item to be sterilized. Placing a containment device on the sterilization wrap material, the containment device configured to reduce expansion of the sterilization wrap material during a sterilization cycle of the sterilizer, the placed sterilization wrap material, base, and containment device comprising a sterilization wrap assembly. In one exemplary embodiment, the step of placing the sterilization wrap material further includes moving a band encircling the base along a support arm of the base to a first position and inserting a portion of the sterilization wrap material having a first sealing surface between the band and the support arm when the band is in the first position. The step of sealing the first sealing surface of the sterilization wrap material further includes moving the band to a second position to secure the sterilization wrap material to the base and locking the band in the second position. The step of placing the sterilization wrap material may further include placing the base on top of the sterilization wrap material and enveloping the base with the items to be sterilized in the sterilization wrap material. The method may further include placing the sterilization wrap assembly in a sterilizer; running a sterilization cycle of the sterilizer; removing the sterilization wrap assembly from the sterilizer; removing the restraining device from the sterilization wrap assembly; moving the band to the first position; verifying that the sterilization wrap material is intact; and expanding the sterilization wrap material from the deployed configuration to the expanded configuration without separating the expandable portion from the first and second non-expandable portions, and removing the sterilization wrap material from the base.

[0015] A seventh exemplary embodiment of the present disclosure provides a sterilization wrap material for sterilizing items in a sterilizer. The sterilization wrap material includes a one-piece sheet member having a first portion of a plurality of accordion folds. The plurality of accordion folds includes a series of spaced, substantially parallel plates with alternating raised and recessed folds, forming a wave pattern of accordion pleats. The accordion pleats traverse the sterilization wrap material (region C). The single sheet is oversized to cover a base having at least one item to be sterilized. The sterilization wrap material further includes first and second longitudinal fold lines and first and second horizontal fold lines that form first and second top panels. The first side panel is defined by a first longitudinal fold line and a second horizontal fold line, the second side panel is defined by a second longitudinal fold line and a second horizontal fold line, the third side panel is defined by a first longitudinal fold line and a first horizontal fold line, and the fourth side panel is defined by a second longitudinal fold line and a first horizontal fold line. Further, the plurality of accordion folds form an expandable configuration, and the plurality of accordion folds move from a contracted state to an expanded state when the sterilization wrap material is removed from the base. In one configuration, the first portion, the first and second top panels, and the first, second, third, and fourth side panels are inseparable.

[0016] An eighth exemplary embodiment of the present disclosure provides a method of using the sterilization wrap material described in the preceding paragraph, the method comprising folding a single sheet member along first and second longitudinal fold lines and first and second horizontal fold lines to form creases along the first and second longitudinal fold lines and first and second horizontal fold lines, respectively, and reinforcing each fold to form a pre-formed bag.

[0017] A ninth exemplary embodiment of the present disclosure provides a preformed sterilization barrier system for at least one item to be sterilized in a sterilizer. The sterilization barrier system includes a sterilization wrap material having a first sealing surface and a first expandable portion having a plurality of folds. In a deployed configuration, the sterilization wrap material covers a base having a support surface, a bottom surface, and a depending skirt, and in an expanded configuration, at least one of the plurality of folds is expanded to increase the size of the sterilization wrap material. In the deployed configuration, a first seal for maintaining a sealed interface between the first sealing surface of the sterilization wrap material and the base forms a sealed volume surrounding the at least one item to be sterilized. The sterilization wrap material of the preformed sterilization barrier system may further include a first non-expandable portion adjacent to the first expandable portion, and in the expanded configuration, the sterilization wrap material is expanded without separating the first expandable portion from the non-expandable portion. In one configuration, the first seal is formed around the entire base between the first sealing surface of the sterilization wrap and the depending skirt. In one configuration, a first seal is formed around the entire base between the first sealing surface of the sterilization wrap and the bottom of the base. In one configuration, a plurality of folds laterally expand the wrap material in the expanded configuration. In one configuration, the sealing device is configured to form a first seal between the first sealing surface of the sterilization wrap material and the base in the deployed configuration. In one configuration, the sealing device is a clamp, and in another configuration, the sealing device is a tension band. The base can include a channel extending circumferentially around the depending skirt of the base. The channel is sized to accommodate the sealing device. The preformed sterilization barrier system further includes a restraining device configured to reduce expansion of the sterilization wrap material during a sterilization cycle of the sterilizer. The restraining device can include a frame that overlies the sterilization wrap material in the deployed configuration. In one configuration, the restraining device is a strap that is positioned over the sterilization wrap material when the sterilization wrap material is in the deployed configuration.In one configuration, the plurality of folds are accordion folds having a series of spaced, substantially parallel plates with alternating raised and recessed folds. The accordion folds form a wave pattern of accordion pleats longitudinally across the sterilization wrap material. In one configuration, the first expandable portion is adjacent to the second non-expandable portion opposite the first non-expandable portion. In the folded configuration, the plurality of folds and the first non-expandable portion overlap the second non-expandable portion. In the deployed configuration, the plurality of folds are at least partially contracted. In one configuration, the plurality of folds are accordion folds that are movable to expand the volume of the sterilization wrap material in the expanded configuration without separating the first and second non-expandable portions from the expandable portions. In one configuration, the preformed sterilization barrier system further comprises a releasable adhesive for maintaining at least a portion of the expandable portion of the sterilization wrap material in a contracted position when the sterilization wrap material is in the deployed configuration. The base may comprise at least one tray. In another configuration, the base is a surgical table. In one configuration, the sealing device is a band configured to seal the sterilization wrap material to the base, the base further including a plurality of arms protruding from the base, the arms configured to support the band. In one configuration, the band is movable along the plurality of arms in a first direction to place the sterilization wrap material and in a second direction to secure the sterilization wrap material in a deployed configuration, wherein the sterilization wrap material is between each of the plurality of arms and the band. The band can include a releasable lock.

[0018] A tenth exemplary embodiment of the present disclosure provides a sterile packaging system for objects that need to be sterilized in a sterilizer. The sterile packaging system includes a base, a wrap, and a sealing device. The base includes a support surface and a depending skirt having sides. The support surface is configured to support the object. The wrap has a main body portion and a lower portion, the main body portion including a top panel and an upper edge panel. The upper edge panel includes a rigid material configured to substantially retain a selected shape. The top panel includes a transparent material that provides at least one transparent wall for viewing the object. The lower portion includes a lower edge panel configured to overlap the sides of the depending skirt. The sealing device seals the lower portion of the wrap to the depending skirt of the base. In one configuration, the top panel includes an inner periphery of the rigid material and an opening. A transparent material is overlaid on the inner periphery. In one configuration, the transparent material is adhesively bonded to the inner periphery of the top panel. In another configuration, the transparent material is heat sealed to the inner periphery of the top panel. In one configuration, the rigid material is a two-ply filter paper material. In another configuration, the rigid material is a formable filter paper configured to retain a selected shape that conforms to the shape of the base. The sterile packaging system may further include a first drape having a length greater than the length of the base, the first drape configured to substantially enclose at least a first portion of the support surface of the base. The first drape further includes a first end, a second end, and an intermediate portion connecting the first and second ends, the first end of the first drape extending around one side of the base and over at least a first portion of the support surface. The second end of the first drape extending around another side of the base and over at least a second portion of the support surface. The sterile packaging system may further include a second drape having a width greater than the width of the base, the second drape configured to substantially enclose at least a second portion of the support surface of the base.The second drape further comprises a first end, a second end, and an intermediate portion connecting the first and second ends, the first end of the second drape extending around one of the sides of the base and covering at least a third portion of the support surface, and the second end of the second drape extending around another of the sides of the base and covering at least a fourth portion of the support surface.

[0019] An eleventh exemplary embodiment of the present disclosure provides a method for sterilizing items in a sterilization apparatus, the method comprising the steps of: placing a sterilization wrap material having a body portion and a bottom portion on a base having a plurality of sides and a support surface for the items to be sterilized, the sterilization wrap material being sized to cover the base; Positioning a sealing device around the side of the base, the sealing device having a band including an inner portion, an outer portion and a compressible layer, the compressible layer surrounding the inner portion of the band. Compressing the compressible layer against the bottom of the wrap and the sides of the base to form a sealed volume surrounding at least one item to be sterilized. Positioning a first drape having a first end, a second end, and an intermediate portion joining the first and second ends, such that the first end of the drape extends around one of the sides of the base and either the intermediate portion or the first end extends to cover at least a first portion of the support surface of the base. Positioning a second drape having a first end, a second end, and an intermediate portion joining the first and second ends, such that the first end of the drape extends around one of the sides of the base and either the intermediate portion or the first end extends to cover at least a second portion of the support surface of the base. In one configuration, the method further includes engaging a compression latch to compress the compressible layer against the bottom of the wrap and the sides of the base to form a seal. The compression latch has a tamper-evident device that indicates whether the compression latch has been released after engagement. In one configuration, the method further includes sterilizing a plurality of bases, each having a sealed volume that encloses at least one item to be sterilized, in the sterilizer, and placing one of the plurality of bases sterilized in one of a plurality of shelves of a rack. Each of the plurality of shelves is configured to hold one of the plurality of bases.

[0020] A twelfth exemplary embodiment of the present disclosure provides a sterile packaging system for objects requiring sterilization in a sterilization apparatus. The sterile packaging system includes a base, a wrap, a sealing interface, and a first drape. The base has a support surface and multiple sides, and the support surface is configured to support an object requiring sterilization. The wrap is sized to cover the sides of the base and the object requiring sterilization. The wrap has a body portion and a lower portion. The sealing interface between the wrap and the base is configured to form a continuous seal between the lower portion of the wrap and the first sealing surface. The first drape is movable between an unfolded position (unfolded position) and a folded position. The first drape is sized to cover at least a first portion of the support surface of the base in the folded position. In one configuration, the sterile packaging system further includes a second drape movable between an unfolded position and a folded position. The second drape is sized to cover at least a second portion of the support surface of the base in the folded position. In one configuration, the lower portion of the wrap includes a tear portion including a tear line and a tear tab. The main body portion is removably connected to the bottom portion along the tear line. In one configuration, the wrap further comprises a top panel and a plurality of side panels extending from the top panel. The top panel includes an inner periphery of rigid material and an opening, with a transparent material overlying the inner periphery. In one configuration, the transparent material is adhesively bonded to the inner periphery of the top panel. In another configuration, the transparent material is heat sealed to the inner periphery of the top panel. In yet another configuration, the wrap further comprises corner portions, each corner having at least one interior pleat and a panel. The panels are positioned near the sides of the wrap and configured to provide a continuous wrap material at the corner portions. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is an exploded view of an exemplary embodiment of a sterile packaging system of the present disclosure.

[0022] [Figure 2]FIG. 2 is a perspective assembled view of the exemplary embodiment of the sterile packaging system of the present disclosure shown in FIG. 1, in which the security device includes a latch.

[0023] [Figure 3] 1 is a perspective view of a fastening device of the sterile packaging system of the present invention. FIG.

[0024] [Figure 4A] FIG. 1 is a top view of an exemplary embodiment of a sterilization wrap of the sterile packaging system of the present disclosure.

[0025] [Figure 4B] FIG. 4B is a perspective view of the sterilization wrap of FIG. 4A, showing the wrap in a partially assembled position.

[0026] [Figure 5A] FIG. 10 is a top view of another exemplary embodiment of a sterilization wrap of the sterile packaging system of the present disclosure.

[0027] [Figure 5B] FIG. 5B is a perspective view of the sterilization wrap of FIG. 5A, showing the wrap in an assembled position.

[0028] [Figure 6] FIG. 1 is a top perspective view of a sterilization wrap having a transparent window.

[0029] [Figure 7] FIG. 1 is a perspective view of another exemplary embodiment of a sterile packaging system of the present disclosure.

[0030] [Figure 8] FIG. 1 is an exploded view of another exemplary embodiment of the present disclosure showing (i) first and second drapes to be placed around the tray, and (ii) a sterilization wrap.

[0031] [Figure 9]9 is an exploded view of the exemplary embodiment of FIG. 8 showing first and second drapes positioned around the tray.

[0032] [Figure 10] FIG. 10 is an exploded view of another embodiment of the present invention showing first and second drapes and a sterilization wrap to be placed around the base of the sterile packaging system of the present invention.

[0033] [Figure 11] 1 is a perspective view of an exemplary embodiment of a holding rack of the sterile packaging system of the present disclosure. FIG.

[0034] [Figure 12] 1 is a perspective view of an exemplary embodiment of a transfer table of the sterile packaging system of the present disclosure; FIG.

[0035] [Figure 13] FIG. 1 is a flow diagram according to a method and apparatus for carrying out an exemplary embodiment of the present disclosure.

[0036] [Figure 14] FIG. 1 is a flow diagram according to a method and apparatus for carrying out an exemplary embodiment of the present disclosure.

[0037] [Figure 15] FIG. 1 is a top view of an exemplary embodiment of a sterilization wrap of the sterile packaging system of the present disclosure.

[0038] [Figure 16] FIG. 16 is a perspective view of the sterilization wrap shown in FIG. 15 in a deployed position. Detailed Description of the Invention

[0039] It should be noted that the same reference numbers appearing in different figures identify the same components of the present invention. While the description of the present invention includes what is presently considered to be the preferred configuration, it should be understood that the present invention is not limited to such configuration. Furthermore, it should be understood that the present invention is not limited to the particular methods, materials, and improvements described herein, and that the terminology used herein is not intended to limit the scope of the present invention. Accordingly, the scope of the present invention is determined solely by the appended claims.

[0040] The present invention relates to a sterilization wrap system that provides increased vent-to-volume ratios for the purpose of sterilizing instruments, medical devices, and the like during sterilization within a sterilizer. The term sterilizer includes, but is not limited to, a housing or device that holds the sterilization system and defines an interior within which a controlled environment is created to achieve the desired sterilization. Sterilizers include autoclaves, hot air ovens, ethylene oxide, low-temperature steam and formaldehyde, sporicidal chemicals, irradiation, chlorine dioxide (CD) gas sterilization, hydrogen peroxide, vaporized hydrogen peroxide, hydrogen peroxide plasma, electron beam, and gas plasma devices.

[0041] This system offers the advantages of both wrapping technology and rigid container systems. By using a base such as a table, tray, or multiple trays as a rigid component without a door, one or more instruments can be placed on it. Using a wrap as a protective cover allows for a high vent-to-volume effect, thereby reducing the time it takes for the sterilant or its by-products to drain. Furthermore, when using a base such as an operating room back table or tray, the back table is integrated with the sterilization wrap system, and the instruments are already organized on the table and ready for use after sterilization, eliminating the need to transfer the instruments from a rigid container to the back table for use in the operating room. Furthermore, by including a first drape as part of the system, and in some configurations also a second drape, additional or separate drapes on the operating room back table are not required. The term "operating room back table" or "back table" generally refers to a table used in the operating room to hold surgical instruments. Operating room back tables are sometimes also referred to as instrument tables or work tables. Back tables can be made of stainless steel, plastic, or other rigid materials and can be any shape or size. Back tables are typically rectangular tables with legs and / or a pedestal. The legs and / or base may or may not be adjustable and / or removable.

[0042] The sterilization packaging system 100 includes a base 10 that provides a support surface 42 and a wrap 20 that provides a protective covering. The base 10 can be any shape and size to provide a support surface. For example, while the base 10 is shown rectangular, the base 10 can be any shape, including, but not limited to, circular, oval, square, or elliptical. This shape of the base 10 is rigid and can serve as a tray, table, sheet, plate, or other type of rigid support base. For example, in one configuration, the base 10 can be a tray 8, as shown in FIG. 8. By way of example, the base 10 includes side walls 12, 14, 16, and 18. It should be understood that the sterilization wrap 20 can take a variety of shapes, including, but not limited to, a sheet, bag, pouch, or partially formed bag. Referring to the figures, FIG. 1 is an exploded view of a sterilization packaging system 100 having a base 10, a wrap 20, and a securing device 30. In this configuration, the securing device 30 includes a compressible layer 32. As shown in FIG. 1 , the base 10, in one configuration, is a surgical room back table 40 having a support surface 42. The support surface 42 supports at least one object 44 requiring sterilization by a sterilization apparatus. The object 44 requiring sterilization may include, but is not limited to, surgical instruments, implants, laboratory supplies, medical equipment, etc. In one configuration, the base 10 includes a depending skirt 46, which may be detachable from legs 48 or a pedestal (not shown). The base 10 may include a flange or sidewall (not shown) along the periphery of the support surface 42 to enable the object 44 to be retained on the support surface 42, particularly in cases where the object may move during transport. Alternatively, or additionally, the base 10 may include dividers, shelves, or compartments for retaining the object 44 (including, but not limited to, surgical instruments and / or trays) in specific areas of the base 10. The base 10 may further include additional fasteners (including, but not limited to, Velcro, magnets, etc.) for releasably holding the object 44 in place. The base 10 may include a laser outline of at least some of the objects 44 .This laser outline identifies the preferred location of a particular object. Other features for organizing and maintaining objects 44 on base 10 are intended to be within the scope of the claims.

[0043] In one configuration, the base 10 includes a drainage system 50 for draining sterilant and / or liquid condensate generated during the sterilization process. The base 10 may include a sloped surface 52 for directing drainage to a predetermined area, as shown in FIG. 1, for example. The sloped surface 52 may be any slope, straight (angular) or curved. In one configuration, the base 10 includes at least one drainage well having a downwardly sloping surface 52 positioned to direct condensed water to a drain outlet 54. In one configuration, the drain outlet 54 has a diameter of approximately 0.5 to 5 inches. In another configuration, the drain outlet 54 has a diameter of approximately 2 to 3 inches. The drain outlet 54 may be any shape and size capable of draining condensate or liquid sterilant from the surface of the base 10. The drain outlet may further include a drain check valve and / or at least one filter. The surface 52 may be frusto-conical to further direct the sterilant and condensate to the drain outlet 54. Alternatively, the drainage system 50 may include a continuous decline that directs the sanitizer and / or liquid condensate to a drainage well or opening 54 near one side of the base 10. It should be understood that the drainage well or opening 54, or multiple drainage wells and / or multiple openings 54, can be located anywhere on the floor of the base, provided the floor is configured to allow for drainage. In yet another configuration, the drainage system 50 may include a slope or decline without a drainage well or opening 54, thereby directing the sanitizer and / or condensate to the edge of the floor of the base 10. The drainage system 50 may include one or more filters within the openings. Those skilled in the art should understand that other drainage systems capable of draining the sanitizer and / or condensate from the floor of the base 10 are possible, and these modifications are intended to be within the scope of the claims. The base 10 may further include a holder for holding the object 44 above the drainage system 50. The holder may be, for example, a plate with perforations, openings, or wells, or a tray configured to be suspended above the base 10. The holder may be integral with the base 10 or may be removable from the base 10. In one example, the holder is a tray 8 shown in FIG.Many configurations for holding implements are known in the art, and in some embodiments, hold implements above a drainage system, and it is understood that these configurations are within the scope of the claims.

[0044] As shown in FIGS. 1-3 , in an exemplary embodiment, the sterilization packaging system 100 includes a fastening device 30. The fastening device 30, in one configuration, is a band 34 having an inner portion 36, an outer portion 38, and a compressible layer 32. In one configuration, the band 34 is a metal band having sufficient lateral flexibility to conform to the length and width of the sidewalls of the base 10. In another configuration, the band 34 is an elastic band having sufficient elasticity to stretch over the base 10 while also having sufficient tension to compress the compressible layer 32 against the wrap 20 and press the wrap 20 against the sealing surface of the base 10. The compressible layer 32 is permanently secured to the inner portion 36 of the band 34 or removably secured to the inner portion 36 of the band 34. In one configuration, the compressible layer 32 is a closed-cell foam and may further include a flat sealing surface that engages the sterilization wrap 20. In one configuration, the fastening device 30 includes a compression latch 28 movable between an open position and a closed position, as shown in FIG. 2 . The compression latch 28 may include a tamper-evident device 6 that can indicate whether the compression latch 28 has been moved from a closed position to an open position. In the open position, the securement device is placed over the sterilization wrap 20 to secure the sterilization wrap 20 to the base 10. The compression latch 28 then engages, compressing the securement device 30 and compressible layer 32 against the sidewalls (e.g., sidewalls 12, 14, 15, 18) of the base 10 and forming a sealed interface between the compressible layer 32 and the sterilization wrap 20. As such, the base 10 includes a support surface 42 and a peripheral sealing surface. The securement device 30, in one configuration, further provides a sealing interface between the securement device 30 and the sterilization wrap 20, and between the base 10 and the sterilization wrap 20. That is, the securement device 30 applies a radial force to the interior surface of the base 10, compressing the compressible layer 32 and the sterilization wrap 20 into sealing engagement with the base 10. It should be appreciated that the sealing interface between the base 10 and the sterilization wrap 20 may be achieved by the force of the securing device 30 pressing against the base 10 .Thus, a seal is formed between the wrap 20 and the sealing surface along the base 10 without the need for adhesives, i.e., glue, sealant polymer, tape, or similar materials. In another exemplary embodiment, the sealed interface is formed by any type of mechanical or non-mechanical seal, including, but not limited to, a clamp or an applied sealant, including, but not limited to, an adhesive, sealant polymer, or tape. Additionally, other types of fastening devices 30 that maintain the sealed interface between the wrap 20 and the base 10 are contemplated, and it is understood that these variations are included herein. For example, shrink wrap or Kraton material can be used to form a clamp around the base 10 to maintain a sealed interface between the wrap 20 and the base 10. In one configuration, the wrap 20 includes multiple seals. For example, the wrap 20 can include two or three seal interfaces between the wrap 20 and the base 10. For example, in one configuration, the wrap 20 includes two continuous adhesive seals. The sterile packaging system 100 can be sized to accommodate an operating room back table. In one example, the sterile packaging system is approximately 24 inches long, approximately 22.5 inches wide, and approximately 12 inches high. However, the size of the sterile packaging system may vary. In some embodiments, the length of the sterile packaging system ranges from 12 inches to 36 inches. As shown in FIG. 2, the sterile packaging system may include a non-expanding device for containing the wrap during the sterilization cycle of the sterilizer. In one configuration, the non-expanding device is a strap 172 secured to at least two sides of the base 10.

[0045] In one configuration, the sealing surface is the sidewalls 12, 14, 16, 18 of the base 10 extending from the periphery of the support surface 42. In another configuration, the sealing surface is the depending skirt 46 of the base 10. In yet another configuration, the sealing surface is the upper outer wall (not shown) extending above the periphery of the support surface 42. For example, in one configuration, the base 10 is a tray 8, and the sealing surface is the upper outer wall extending above the periphery of the support surface 42. Typically, the base 10 is formed of stainless steel, and therefore the sealing surface is also stainless steel. However, it should be noted that the base 10 may be constructed of other types of materials that do not deteriorate when exposed to a sterilant, and therefore the sealing surface is not limited to such materials. The sealing surface may include a channel (not shown) that at least partially surrounds the sealing surface. Additionally, multiple sealing surfaces may be used to create more than one sealing interface.

[0046] The sterilization wrap 20 comes in a variety of shapes and styles and can be applied over or under the support surface 42 of the base 10. Typically, the sterilization wrap 20 is a rigid material configured to substantially retain a selected shape. In one configuration, the wrap 20 is formed from a tear-resistant material. The sterilization wrap 20 may be a single-layer or multi-layer material. The wrap 20 may be composed of layers of different materials. The material may be made of spunbound, meltblown, spunbound laminate (SMS) fabric, polypropylene, Tyvek, or other types of materials with filtration capabilities. Alternatively, the material may be gamma ray resistant. For example, the material may be gas-impermeable, providing a strong and durable sterilization barrier. In yet another configuration, the material is permeable to gases and water vapor but not liquids. In this configuration, the material allows air and vapor to pass through but not liquid droplets.

[0047] The material of the wrap 20 is selected based on the required filtering and the type of sterilization process being used. For example, a combination of Tyvek and plastic would not be used in a steam sterilization process because it would melt. However, a combination of Tyvek and plastic can be used in an ethylene oxide (EtO) sterilizer. If steam must be able to penetrate the material, a filter material can be used. In some configurations, the sterilization wrap 20 is a disposable material, while in other configurations, the sterilization wrap 20 is reusable. Furthermore, the sterilization wrap 20 may be constructed of a single material or multiple materials. Referring to FIGS. 4A and 4B, the wrap 20 is formed from a filter paper blank 80 with cutouts 86 at each corner 82 to form panels 84a, 84b, 84c, and 84d. The ends of each panel 84a, 84b, 84c, and 84d form, for example, sealed edges 82a and 82b, which can be sealed together to form a closed end 88. For example, sealing edge 82a and corresponding sealing edge 82b may be joined by ultrasonic welding, adhesive, tape, or other methods known in the art. As shown in Figures 4A and 4B, in one configuration, sealing edges 82a, 82b are sealed together with adhesive tape 90.

[0048] As shown in FIGS. 5A and 5B, another configuration of the wrap 20 is formed from a filter paper blank 92, with each corner 94 folded over to provide a continuous material around each corner 94. In one configuration, each corner 94 of the wrap 20 includes folds 96a, 96b, 96c, and 96d. The folds 96a and 96b form an interior pleat 98a on one side 76 of the wrap 20, and the folds 96c and 96d form an interior pleat 98b on the adjacent side 78 of the wrap. The folds 96b and 96c form a panel 98c that folds over the adjacent sides 76 and 78 over the exterior of the wrap 20. The other corner 94 of the blank 92 can be folded in a similar manner, thereby providing a continuous material around the base 10. The fastening device 30 is then placed over the wrap 20 to secure the wrap 20 to the base 10. In one exemplary embodiment, the wrap is oversized to allow for some expansion during the sterilization process. In another exemplary embodiment, the corners 94 are held together by ultrasonic welding, adhesive, tape, or other manufacturing methods known in the art.

[0049] As shown in FIG. 2 , the wrap 20 can include a main body portion 22 and a bottom portion 24. As shown in FIGS. 2 and 6 , in one configuration, the main body portion 22 includes a top panel 26 with a transparent window 48 that allows a user to view the contents within the sterile packaging system 100. In one configuration, the transparent window 48 is comprised of a transparent plastic film. The transparent plastic film is sealed to the material of the wrap 20 before and during use, but as shown in FIG. 6 , the transparent plastic film may be removable by a user to allow the user to access the contents within the wrap 20. For example, the wrap 20 can include an opening in the top panel 26 formed by an upper edge 56 of the top panel 26. The opening is closed by the transparent window 48. For example, in one configuration, the peripheral edge of the transparent window 48 overlaps the upper edge 56 of the wrap 20 and is removably adhered to the wrap material 20 by adhesive, heat sealing, or the like, such that at least a portion of the transparent window 48 is separable from the wrap material 20 when a user applies force. The transparent window 48 is provided with a tab 58 that allows a user to easily pull the transparent window 48 or a portion thereof away from the upper edge 56 .

[0050] As shown in FIG. 7 , in one configuration, the sterilization packaging system 20 includes a frangible line 72 that circumscribes the sterilization wrap 20 between the main body portion 22 and the lower portion 24. The frangible line 72 may include, but is not limited to, a frangible section, a perforation, a cutting guide line, a score line, an embossed portion, a seam, or a combination thereof. The frangible line 72 allows the main body portion 22 to be removed from the lower portion 24 along the frangible line 72. A tear tab or zipper 74 may be provided along the frangible line 72 to facilitate removal of the main body portion 22 from the lower portion 24. In one configuration, the frangible line 72 includes a tear line along the perimeter of the lower portion 24 of the wrap 20. The frangible line 72 may include additional tear-resistant material bonded to the frangible line 72. In one configuration, the securement device 30 retains the lower portion 24 with the main body portion 22 removed. Engagement of tear tab or zipper 74 separates main portion 22 and lower portion 24. Lower portion 24 is sealed to base 10 so that main portion 22 can be removed while lower portion 24 hangs down and serves as a protective drape when sterile packaging system 20 is in the sterile field.

[0051] Additionally, as shown in FIGS. 8, 9, and 10, the base 10, or at least one tray 8, can be draped over the base 10 prior to placement of the sterilization wrap 20, reducing the risk of contamination when the wrap 20 is removed after the sterilization process is complete (i.e., after the sterile packaging system 100 completes a sterilization cycle in a sterilization device such as an autoclave). In one configuration, as shown in FIG. 8, the drape 110 includes a first end 112 and an oppositely disposed second end 114, forming two ends of the drape 110. The drape 110 further includes an intermediate portion between the first and second ends (the intermediate portion located below the tray 8 in FIG. 8 and below the base 10 in FIG. 10). The drape 110 also includes a first side 118 that is substantially parallel to the side 12 of the base 10 (see FIG. 1) or the tray 8 having a length. In one configuration, the first side 118 of the drape 110 has a length at least twice the length of the tray 8, and the first end 112 and second end 114 have widths substantially the same size as the width of the tray 8. Typically, the length of the drape 110 is between two and four times the length of the base 10 or tray 8. In one configuration, the first end 112 and second end 114 are configured to fold around the two sides 12, 16 of the base 10 or the corresponding sides of the tray 8, respectively, to prevent contamination of the contents on the base 10 or tray 8 when the sterilization wrap 20 is removed. In one configuration, the sterile packaging system 100 further includes a drape 130. The drape 130 includes a first end 132 and an oppositely disposed second end 134, forming two ends of the second drape. The drape 130 further includes an intermediate portion 136 between the first end 132 and the second end 134. The drape 130 further includes a first side 138 between the first end 132 and the second end 134. The length of the first end 132 and the second end 134 is substantially the same size as the length of the base 10 or tray 8, and the first side 138 of the drape 130 is substantially parallel to the width of the base 10 or tray 8. In one configuration, the width is between two and four times the width of the base 10 or tray 8, and each of the first end 132 and the second end 134 is configured to be folded over the base 10 or tray 8.In one configuration, the first and / or second drapes 110, 130 allow for direct use of sterilized objects contained in the base 10 or tray 8, eliminating the need to transfer the sterilized objects 44 from the base 10 or tray 8 to a separately draped table. In one configuration, when the sterilization wrap 20 is removed, the first drape 110 and / or second drape 130 unfolds from the base 10 or tray 8 and hangs below the surface of the base 10 or tray 8. In one configuration, the first drape 110 and / or second drape 130 moves from a folded position, such as shown in FIG. 9, to an unfolded (unfolded) position, such as shown in FIG. 8, when the sterilization wrap 20 is removed. In another configuration, the first drape 110 and / or second drape 130 is moved from the folded position to the unfolded position by an operator. Thus, in the folded position, the first drape 110 and the second drape 130 function as drapes to maintain a sterile field in an operating room or other area where a sterile field is required. It should be understood that the drapes 110 and 130 are not limited in shape as well as size. Generally, the drapes are sized larger than the size of the applicable base 10 or tray 8, with the ends of the drapes overlapping each other on the applicable base 10 or tray 8. In one configuration, the drape 110 is positioned over a portion of the support surface 42 of the base 10 or a portion of the tray 8. In one configuration, the drape 130 overlies a portion of the support surface 42 of the base 10 or a portion of the tray 8. In another configuration, one or both of the first drape 110 and the second drape 130 substantially covers the entire support surface 42 of the base or tray 8. In yet another configuration, one or both of the first drape 110 and the second drape 130 cover a portion of the object 44 to be sterilized. In yet another configuration, one or both of the first drape 110 and the second drape 130 cover the entire, or substantially the entire, object 44 to be sterilized. It is understood that the sterile packaging systems shown in Figures 8, 9, and 10 can include additional features described herein and shown in Figures 1, 2, 3, 4A, 4B, 5A, 5B, 6, and 7.As a non-limiting example, the sterile packaging system shown in Figures 8, 9, and 10 may include the fastening device 30 described in Figures 1-3. As shown in Figure 9, in one configuration, a wrap support 170 extends from the base 10. The wrap support 170 is foldable in one configuration and removable in another configuration.

[0052] When sealed, the wrap 20 and the support surface 42 of the base 10 define an interior region 174, providing a continuous barrier against bacteria or other types of live microorganisms, including infectious agents (fungi, bacteria, viruses, spore forms, etc.). The drape 110 (in some configurations, the drape 110 and the drape 130) forms a second (secondary) continuous barrier within the interior region and may include a secondary seal within the interior region 174. In one configuration, the drape 110 and the drape 130 are sealed with an adhesive, tape, or other sealant to form the secondary seal. In another configuration, only one of the drapes 110 or 130 is used to provide the secondary continuous barrier, which in some configurations also includes a secondary seal. It should be noted that the drape 110 and / or the drape 130 can be sized depending on whether one drape or two drapes are desired to provide a continuous barrier (and optionally to provide a secondary seal).

[0053] The sterilization wrap 20 can define a vent passage area 110 of the sterile packaging system 100. The vent passage area 110 refers to the total area available for gas, vapor, and / or liquid entry and exit relative to the interior volume of the sterile packaging system 100. "Vent passage area to volume ratio" refers to the ratio of the total vent passage area of the sterile packaging system 100 to the interior volume of the sterilization wrap system. This vent passage area to volume ratio increases the area exposed to the sterilant and reduces the drying time required to remove condensation, moisture, and sterilant residue from the sterilized items.

[0054] As shown in FIG. 11 , the sterilization packaging system 100 can include multiple bases 10 arranged on a rack system 150. In one embodiment, the rack system includes multiple shelves 152 that receive bases 10 (or bases 10 with trays 8) wrapped in sterilization wrap 20. The rack system 150 has side walls 154 and a door 156 that, when the door is in an open position, allows multiple bases 10 and / or multiple bases 10 with trays 8 to be loaded onto the multiple shelves. In one configuration, the shelves 152 are removable. In another configuration, the shelves are extendable to easily receive the bases. Typically, multiple bases 10 (each having a wrap 20 that encases and seals the base 10) are inserted into the rack system 150 and placed on the shelves 152 after the bases 10 sealed with the wrap 20 have been sterilized in a sterilizer. Thus, a large number of bases can be stored in the rack system 150 after the bases have been processed in the sterilizer. In one embodiment, the rack system 150 includes wheels 158 to allow the rack system 150 holding a plurality of processed bases 10 to be transported to a surgical suite.

[0055] In one configuration, the base 10 includes a locking mechanism for releasably locking the base to a pedestal, legs, or transport cart 192. The transport cart 192 is comprised of a frame 252, a push handle 254, and wheels 256. If the transport cart 192 is being used as a table in a surgical backroom, the transport cart 192 may optionally not include the push handle 254 or locking mechanism. The transfer cart 192 may be made from a durable material that is strong enough to maintain its shape under significant weight and that can be sterilized. Ideally, the transfer cart 192 is constructed from steel or aluminum alloy, or a combination thereof. It should be understood that the transfer cart 192 is merely an exemplary embodiment of the transfer cart 192.

[0056] The transport cart 192 may further include a sled (not shown) with wheels 260. The sled slides along guide rails on the transport cart 192 when the sled and base 10 are loaded into the sterilizer. The transport cart 192 is rigid enough to support the weight of the base 10 and sled, or other similar sterilization equipment. In one configuration, the base 10 is releasably locked to the sled via a locking mechanism 262. The locking mechanism 262 provides a means for removably securing the base 10 to the transport cart 192. Exemplary embodiments of the locking mechanism 262 include any means capable of securely securing the base to the transport cart 192 (e.g., the sled of the transport cart 192), such that the base 10 only moves when the transport cart 192 moves. Furthermore, the sled is releasably locked to the transport cart 192 via the locking mechanism 262. The locking mechanism 262 provides a means for removably securing the sled to the transport cart 192. Exemplary embodiments of the locking mechanism 262 include any means by which the sled can be securely secured to the transfer cart 192 such that the sled only moves when the transfer cart 192 moves. The transfer cart 192 may further include a locking mechanism for releasably locking the transfer cart 192 to the sterilizer. Thus, when the sled and / or base 10 are loaded into the sterilizer, the transfer cart 192 can be locked relative to the sterilizer to prevent unwanted movement of the transfer cart 192 during transfer of the load from the transfer cart 192 to the sterilizer. Exemplary embodiments of the locking mechanism include clamps, latches, slots, bolts, screws, and the like. In another configuration, the base 10 is secured to the transfer cart 192. For example, in one configuration, the base 10 is integral with and permanently secured to the transfer cart 192.

[0057] The push handles 254 on the transport cart 192 provide a means for a user to more easily push or pull the transport cart 192. The push handles 254 may be located on opposite sides of the transport cart 192. Each push handle 254 spans the width of the transport cart 192. It should be understood that various configurations of the push handles 254 are possible, including those in which the push handles 254 are located on all sides of the transport cart 192 and those in which the push handles 254 are located on only one side.

[0058] One advantage of loading a base 10, such as an operating room back table, directly onto a transfer cart 192 and then into a sterilizer is that once the sterilization cycle is complete, the base 10 (table) can be reloaded onto the transfer cart 192 and moved directly into the operating room for reuse. Because the instruments and other objects are already organized on trays prior to sterilization, they can be used without further handling or organization. In another configuration, the base 10 and transfer cart 192 are loaded together into a ground-loading sterilizer. In this configuration, the transfer cart 192, base 10, and the instruments contained therein are sterilized in the ground-loading sterilizer. This prevents the base 10 from being separated from the transfer cart 192 during sterilization or transport.

[0059] As shown in FIG. 13, the following steps are followed to sterilize items in a sterilizer. First, in step 200, a sterilization wrap 20 is placed over a base 10. In one configuration, the base 10 has a support surface on which a plurality of instruments to be sterilized are placed. In one configuration, the sterilization wrap 20 includes a body portion 22 and a bottom portion 24, and the sterilization wrap 20 is sized to cover the base. Optionally, in one configuration, a drape 110 is placed before the sterilization wrap material is placed in step 214. The drape 110 has a first end 112, a second end 114, and a middle portion connecting the first and second ends. The first end 112 of the drape 110 extends around one of the sides of the base 10, and either the middle portion or the first end 112 extends over at least a first portion of the support surface of the base 10. In this configuration, the base is a base 10 or a tray 8. Further, in step 216, a drape 130 is placed. The drape 130 has a first end 132, a second end 134, and an intermediate portion connecting the first end 132 and the second end 134. The first end 132 of the drape 130 extends around one of the sides of the base, and either the intermediate portion or the first end 132 extends over at least a second portion of the support surface of the base.

[0060] Next, in step 204, sealing device 30 is placed around the sides of base 10. Sealing device 30 includes band 34, which includes inner portion 36 and outer portion 38, and compressible layer 32, which surrounds inner portion 36 of band 34. In step 206, compressible layer 32 is compressed against bottom portion 24 of wrap 20 and the sides of base 10 to form a sealed volume that encloses at least one item to be sterilized.

[0061] In step 208, the compression latch 28 is engaged, compressing the compressible layer against the bottom 24 of the wrap 20 and the sides of the base 10 to form a seal. The compression latch 28 is equipped with a tamper-evident device that indicates whether the compression latch 28 is released after engagement. In step 210, a plurality of bases 10 are sterilized. Each of the plurality of bases 10 has an enclosed space that encloses at least one item to be sterilized. After sterilization, in step 212, the plurality of bases are arranged, as needed, on a plurality of shelves of a rack 150. Each of the plurality of shelves 152 is configured to hold one of the plurality of bases. As an alternative to this step, other methods disclosed herein can be used to form a seal between the wrap 20 and the base 10. Other methods include, but are not limited to, gluing the wrap 20 to the base 10.

[0062] In another exemplary embodiment 300, as shown in FIG. 14 , the following steps are followed when sterilizing an item in a sterilizer. First, in step 302, an object requiring sterilization is placed on base 10. Optionally, in step 304, the object requiring sterilization is at least partially encased in drape 110 or 130. In step 306, the object requiring sterilization, now at least partially encased in drape 110 or 130, is enclosed in wrap 20. Finally, in step 308, the wrap is engaged with a sealing surface of base 10. In one configuration, the sealing surface is a continuous seal. In one configuration, the sealing surface is additionally or alternatively a perimeter seal. In one exemplary embodiment, the object is substantially enclosed by drape 110 or 130. In another exemplary embodiment, the object is substantially enclosed by both drape 110 and drape 130. In one exemplary embodiment, step 306 (enclosing the object requiring sterilization, at least partially enclosed within the first drape, in a wrap) includes forming at least one corner of the wrap 20, the at least one foldable corner having interior pleats (e.g., 98a, 98b) and a panel (e.g., 98c), and folding the corner near a side of the wrap 20 to provide a continuous wrap material at the corner (shown in FIG. 5B).

[0063] As shown in Figures 15 and 16, in one embodiment, the sterilization wrap 20 is expandable. For example, as shown in Figure 15, the sterilization wrap 20 includes a single sheet member 400. The sheet member 400 has a first portion of a plurality of accordion folds 402. The first portion includes a series of spaced, substantially parallel plates 404 with alternating raised and depressed folds 406, thereby forming a wave pattern of accordion pleats across the sterilization wrap material (Region C). The single sheet member 400 is oversized to cover a base 10 having at least one object to be sterilized. In one exemplary embodiment, the single sheet member 400 does not have any additional folds, and is sized to wrap around the base 10 to completely cover it. In another exemplary embodiment, the sheet member 400 may include longitudinal fold lines 410, 412 and transverse fold lines 414, 416. Vertical fold line 410, horizontal fold lines 414, 416, and the first fold of accordion fold 402 form top panel A, and vertical fold line 412, horizontal fold lines 414, 416, and the last fold of accordion fold 402 form top panel B. Side panel D is formed by vertical fold line 410, horizontal fold line 416, and the first fold of accordion fold 402. Side panel E is formed by vertical fold line 412, horizontal fold line 412, and the last fold of accordion fold 402. Similarly, side panel F is formed by vertical fold line 410, horizontal fold line 414, and the first fold of accordion fold 402. Side panel G is formed by vertical fold line 412, horizontal fold line 414, and the last fold of accordion fold 402. The expandable portion, e.g., accordion fold portion 402, is configured to be movable between a contracted state and an expanded state, thereby allowing sheet member 400 to be used with bases 10 of various sizes. Alternatively or additionally, providing an expandable wrap 20 allows wrap 20 to be removed from base 10 without contaminating the sterile contents on base 10.That is, when the wrap 20 is removed from the base 10 after sterilization, expanding the wrap 20 away from the sterilized surface reduces the likelihood that the outer portions of the sterilization wrap 20 will come into contact with the sterilized surface within the wrap 20. In one embodiment, the top panel and side panels are inseparable from one another. In another configuration, the top panel A and side panels D and F are adjacent to one another and form a first section 418 of the sterilization wrap 20, and the top panel B and side panels E and G are adjacent to one another and form a second section 420 that is separable from the first section 418 of the sterilization wrap 20. In one embodiment, the first section 418 of the sterilization wrap 20 and the second section 420 of the sterilization wrap 20 each include an accordion fold 402. In another embodiment, only one of the first section 418 or the second section 420 includes an accordion fold 402.

[0064] An inner periphery 408 of the sheet member 400 may be secured to the base 10. In one example, the securing device 30 provides a sealed interface between the securing device 30 and the sheet member 400, and between the base 10 and the sheet member 400.

[0065] In one embodiment, a single sheet member 400 is folded along longitudinal fold lines 410, 412 and transverse fold lines 414, 416, forming creases along the longitudinal and transverse fold lines, respectively. In one exemplary embodiment, each of the fold lines 410, 412, 414, 416 is reinforced to form a preformed bag. It should be understood that the wrap 20 shown in Figures 15 and 16 can be used with the sterile packaging systems shown in Figures 1, 2, 7, 8, 9, and 10 and can include additional features described herein. As a non-limiting example, the fastening device 30 described in Figures 1-3 can be used with the wrap 20 shown in Figures 15 and 16.

[0066] The present invention contemplates many variations and modifications, and thus, while the presently preferred forms of the apparatus and method have been shown and described, and several modifications and alternatives have been discussed, it will be readily apparent to those skilled in the art that various additional changes and modifications could be made without departing from the scope of the invention as defined and distinguished by the claims.

Claims

1. 1. A sterilization packaging system for an object that needs to be sterilized in a sterilization device, comprising: a base having a support surface and a plurality of sides, the support surface configured to support an object requiring sterilization; a wrap having a size to cover the side of the base and an object requiring sterilization, the wrap having a body portion and a bottom portion; a sealing interface between the lower portion of the wrap and the base, the sealing interface configured to form a continuous seal between the lower portion of the wrap and a first sealing surface; a first drape movable between an unfolded position and a folded position and sized to cover at least a first portion of the support surface of the base in the folded position; A sterile packaging system comprising:

2. 10. The sterile packaging system of claim 1, further comprising a second drape movable between an unfolded position and a folded position, the first drape being sized to cover at least a second portion of the support surface of the base in the folded position.

3. 2. The sterile packaging system of claim 1, wherein the first drape further comprises a first end, a second end, and an intermediate portion connecting the first end and the second end, and wherein in the folded position, the first end of the first drape overlaps the second end of the first drape on the support surface.

4. 3. The sterile packaging system of claim 2, wherein the second drape further comprises a first end, a second end, and an intermediate portion connecting the first end and the second end, and in the folded position, the first end of the second drape overlaps the second end of the second drape on the support surface.

5. The sterile packaging system of claim 1 , wherein the first sealing surface is a surface of the periphery of the base.

6. 3. The sterile packaging system of claim 2, wherein at least one of the first drape and the second drape is between the first seal interface and the base of the lower portion of the wrap.

7. The sterile packaging system of claim 1 , wherein the base is a tray.

8. 10. The sterile packaging system of claim 1, wherein the base is a table having multiple sides, the multiple sides of the table forming a depending skirt.

9. 9. The sterile packaging system of claim 8, further comprising a clamp configured to form a seal between the depending skirt of the base and the lower portion of the wrap.

10. 10. The sterile packaging system of claim 9, wherein the clamp is a band having an inner portion, an outer portion, and a compressible layer, the compressible layer surrounding the inner portion of the band, the band compressing the compressible layer against the wrap and the depending skirt of the base to form a seal.

11. 11. The sterile packaging system of claim 10, wherein the band further comprises a compression latch movable between an open position for applying and releasing the band and a closed position for forming a compression seal, the compression latch having a tamper-evident device that indicates whether the compression latch has been moved from the closed position to the open position to release the band.

12. 2. The sterile packaging system of claim 1, wherein the lower portion of the wrap includes a tear portion, the tear portion comprising a tear line and a tear tab, and the body portion is removably connected to the lower portion along the tear line.

13. 13. The sterile packaging system of claim 12, wherein the tear line comprises a score line along the perimeter of the bottom portion of the wrap.

14. 10. The sterile packaging system of claim 1, further comprising a non-inflatable device for holding down the wrap during sterilization, the non-inflatable device being a strap secured to at least two of the sides of the base.

15. 10. The sterile packaging system of claim 1, wherein the base further comprises a wrap support extending from the base, the wrap support being at least one of foldable and removable.

16. moreover, a plurality of bases, each having the wrap, the first drape, the second drape, and a continuous seal between the lower portion of the wrap and the first sealing surface; a rack having a plurality of shelves, each of the plurality of shelves configured to hold one of the plurality of bases having the wrap thereon after sterilization in a sterilizer; 10. The sterile packaging system of claim 1, comprising:

17. 10. The sterile packaging system of claim 1, wherein the wrap and the base define an interior region, and at least one of the first drape and the second drape forms a secondary seal within the interior region.

18. 1. A sterilization packaging system for an object that needs to be sterilized in a sterilization device, comprising: a base having a support surface configured to support the object to be sterilized and a continuous sealing surface; a first drape sized to cover the base and at least a first portion of the object to be sterilized; a wrap sized to engage the continuous sealing surface and enclose the first drape and the object to be sterilized; A sterile packaging system comprising:

19. 20. The sterile packaging system of claim 18, further comprising a second drape sized to cover at least a second portion of the object requiring sterilization.

20. 20. The sterile packaging system of claim 18, further comprising a retainer configured to hold the wrap against the continuous sealing surface.

21. 21. The sterile packaging system of claim 20, wherein the retainer is further configured to engage the wrap with the continuous sealing surface.

22. 21. The sterile packaging system of claim 20, wherein the retainer further comprises a compressible layer and a band, the band being movable between an open configuration and a sealed configuration.

23. 21. The sterile packaging system of claim 20, wherein the retainer includes a tamper-evident element.

24. 20. The sterile packaging system of claim 18, wherein the continuous sealing surface defines a perimeter of the base.

25. moreover, a plurality of bases, each having the wrap, the first drape, and the retainer that holds the wrap against the continuous sealing surface; a rack having a plurality of shelves, each of the plurality of shelves configured to hold one of the plurality of bases having the wrap thereon after sterilization in a sterilizer; 21. The sterile packaging system of claim 20, comprising:

26. 1. A method of preparing an object requiring sterilization in a sterilization apparatus, comprising: placing the object requiring sterilization on a base; at least partially encasing the object requiring sterilization within a first drape; enclosing the object requiring sterilization at least partially enclosed within the first drape in a wrap; engaging the wrap with a continuous sealing surface of the base; A method comprising:

27. 27. The method of claim 26, wherein engaging the wrap with the continuous sealing surface of the base includes placing a band in an engaging configuration to hold a portion of the wrap between the band and the continuous sealing surface of the base.

28. 27. The method of claim 26, wherein a portion of the wrap comprises a compressible porous layer.

29. 27. The method of claim 26, further comprising at least partially encasing a second portion of the object requiring sterilization in a second drape.

30. 27. The method of claim 26, wherein the step of enclosing the object requiring sterilization at least partially wrapped within the first drape in the wrap further comprises forming at least one corner of the wrap that is foldable and has an interior pleat and a panel, and folding the corner near a side of the wrap to provide a continuous wrap material at the corner.

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